ISO 14971:2019 Risk Management Course Content
This ISO 14971 Risk Management Course provides you with the Tools, Skills and Knowledge necessary to plan and audit a Risk Management Programme for your medical device (or component) manufacturing organization.
This course is intended for those who:
- need to plan and conduct an internal audit medical device risk management for their organization,
- wish to offer consultancy support in MDMS,
- you are Management Representative for their organization and are the Audit Programme Manager for MDMS internal audits.
- wish to improve your career prospects.
This comprehensive Course covering all aspects of medical device risk management is divided into four Modules …
- Module 0: Introduction and background to the Course
- Module 1: Application of Risk Management to Medical Devices based on the auditing standard ISO 14971:2019 and includes …
- Risk Management Process
- Management Responsibilities
- Qualification of Personnel
- Risk Management Plan
- Risk Management File
- Risk Analysis process
- Intended use and reasonably foreseeable misuse
- Identification of characteristics related to safety
- Identification of hazards and hazardous situations
- Risk Estimation
- Implementation of risk controls
- Residual risk evaluation
- Benefit-risk analysis
- Completeness of risk control
- Online Module 1 Examination
- Module 2: Selecting and applying the methods and tools used, including …
- SWIFT – What-If Analysis
- Checklists – various types
- PHA – Preliminary Hazard Analysis
- FTA – Fault Tree Analysis
- ETA – Event Tree Analysis
- FMEA– Failure Mode and Effects Analysis (general)
- dFMEA – Design FMEA
- pFMEA – Process FMEA
- uFMEA – User FMEA
- HAZOP – Hazard and Operability Study
- HACCP – Hazard Analysis & Critical Control Points
- Online Module 2 Examination
These include examples. illustrative figures and a set of Hazard Analysis Templates, namely:
- Risk Management Process
- Terms and Definitions for ISO 14971
- Example Design FMEA
- Example Process FMEA
- Example User FMEA
- Example FMECA Rating Table
- Note: Choice of Tools used for Riak Assessment
- Note: HACCP Principles and Hazard Analysis
- Note: Supply Chain Integrity Best Practice
All Modules have a full resume and scaling capabilities. This means, for example, you can…
- Start a Module at work on your Work Station running on Windows 10,
- Continue the Module on the train home on your iPad running on iOS 11 and,
- Complete the Module at home on your Notebook PC running on Windows 8.1
For this foundation course, the minimum of a Secondary School Certificate (such as a High School Diploma, Baccalaureate or similar National Vocational Qualification) combined with 5 years’ work experience is recommended.
A knowledge of ISO 13485 would be an advantage but not necessary.
You do not have to provide us with any evidence of your qualifications and experience. However, if you do not meet these requirements, you can expect to struggle with the Program.
These alternatives may be a better fit and save you time and money …
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